Closed system mouthpiece with light and heat generation to activate a formulation to increase its volume

ABSTRACT

A method employs a closed system mouthpiece using light and heat generation to activate a gel formulation to increase its volume. The gel formulation is coated into the mouthpiece, which is inserted into the user&#39;s mouth. Application of heat above a threshold temperature causes the gel to transform into foam and expand out of the mouthpiece and into the oral cavity. The mouthpiece creates a hermetic seal such that the foam expands out throughout the oral cavity into nooks and crannies that are normally difficult to access. Activation of a light source embedded within the mouthpiece enhances the bacteria killing properties of the foam material. The pH balance of the mouth is restored by the inventive method and apparatus to a neutral level in the range of 6.75 to 7.25.

This application is a Divisional of application Ser. No. 13/956,787,filed on Aug. 1, 2013. The present invention relates to a closed systemmouthpiece with light and heat generation to activate a formulation toincrease its volume.

BACKGROUND OF THE INVENTION

Most natural environments harbor an incredibly diverse collection ofmicrobial species. Within these communities, bacteria compete with theirneighbors for space and resources.

The mouth is no different, with a warm, nutrient rich environment,continuously bathed with saliva, and with a pH normally between6.75-7.25, essentially neutral between acidic and basic. The oral cavityis a home for around 600 species and 8 billion bacteria all livingtogether and vying for nutrients and resources to feed themselves, mostof which are beneficial organisms and live in harmony with each otherand the host.

How do all of these bacteria in one's mouth live together over time tomaintain this natural healthy balance between good bacteria and the badbacteria. Survival is key and the natural selection theory holds trueover time. The microbiological community figures out how to livetogether, and not only survive, but to thrive in this natural ecosystem.The ability to work together and share the resources in their communityis referred to as homeostasis, a balancing act that lives in our mouthin spite of numerous external changes.

However, when the external changes are too powerful for the homeostaticbalance, the bacterial balance in the mouth shifts significantly. Thebacteria that can cause harm begin to dominate the beneficial organisms.That is, shifts in the environment can throw the balance off betweenbacteria that have a positive effect vs. bacteria that cause disease.The three main environmental shifts are the pH of the mouth (acid andbase balance), the availability of nutrients (food and resources) in ourmouths, and how well we are cleaning the plaque off our teeth and gums;especially in the hard to reach places.

It is not the individual bacteria alone that cause disease, but theenvironment in our mouth that is altered by our diet and our ability tocontrol plaque, both events we control by our daily actions. Theseactions directly affect the environmental circumstances in regulatingand controlling the quality of the biofilm (bacterial plaque) in ourmouths, the types of nutrients we put into our mouths, and the resultingpH.

For people who have a diet high in proteins (i.e., meat, processedfoods) and simple carbohydrates or sugars, a low pH unhealthy, acidicenvironment is formed. This helps the acid tolerating bacteria like s.mutans that cause disease and displaces the oral-health associated,neutral pH bacteria such as s. salivarius. Another example of thisphenomenon is the gram-negative anaerobic bacteria that also thrive inthe more acidic environment that causes an inflammatory cascade to occurin the periodontal tissues and resulting gingivitis. Similarly, the badbreath causing bacteria that live in between the teeth and in the deepsurfaces of the tongue also thrive in the acidic environment thatdecreases saliva flow and increases colonization of the harmfulbacteria. So, by having a lower pH in our mouths because of what we putin our mouths and due to our food selection, the bacteria that causedecay, gum disease and bad breath start dominating the healthy bacteria.Couple this with poor plaque control, and the environment is now createdfor a shift in the bacterial populations to disease producing organismsand a bacterial load that not only impacts oral health, but overallhealth as well.

Today, the link between pathogenic bacteria originating in the oralcavity causing inflammation in other areas of the body has beenscientifically demonstrated.

Dr. Han and her co-investigators have begun identifying the mechanismsthat allow F. nucleatum to move from the mouth into the bloodstream andthroughout the body—taking other bacteria with it and leavingdestruction in their path (Molecular Microbiology, December 2011, Vol.82:6, pp. 1468-1480). Her team has shown that F. nucleatum can inducepreterm birth and stillbirth in animals and humans (see, for example,Obstetrics & Gynecology. February 2010, Vol. 115: suppl 2, part 2, pp.442-445). Other researchers have linked this phenomenon to colorectalcancer (Genome Research, Oct. 18, 2011) and infections and abscesses inall the internal organs, including in the brain and lungs.

By controlling pH to maintain it within desirable limits, it is possibleto alter the plaque biofilm, remineralize existing lesions and helpprevent oral disease going forward.

Plaque is a very sticky substance that forms on the teeth in a matter ofminutes and causes gum inflammation in a matter of days if the plaque isnot timely removed. The areas in the mouth that are difficult to cleanare the surfaces of the tongue and areas between the teeth that createan anaerobic environment. Without oxygen, the bacteria that cause badbreath and periodontal disease now colonize if they are not timelyremoved. If we look at ways to mitigate the dominance of the badbacteria over the healthy ones, if we can impact the pH of our mouthsand effectively decrease the bad bacteria in the mouth, we will have aneffective way to promote good health in the mouth. The objective is tochange the environment from oxygen poor-low pH sites where thepathogenic bacteria thrive to a safer, more effective way to rebalancehomeostasis in the mouth toward enhanced health with anoxygen-rich-higher ph.

We know that only 10% of the population flosses regularly and that 75%of the population over the age of 35 has some form of gum disease. Thelatest data from the NIH and the Academy of Periodontics is that halfthe adult population has some form of periodontal disease, which is guminflammation along with bone loss. These chronic type lesions are theones that show an increase in bacterial load in the mouth which impactsareas all over the body as the oral disease bacteria have the chance tobe disseminated to other areas in the body. The connection between oralhealth and overall health is an emerging science of oral systemicmedicine and has been growing over the last decade. Moise Desvarieux, aninfectious disease epidemiologist at Columbia University, conductedstudies showing the link between chronic infections, includingperiodontal infections, and cardiovascular disease. Dr. Angela Kamer,Assistant Professor of Periodontology & Implant Dentistry at New YorkUniversity, led a research team that found a connection betweenperiodontal disease and cognitive function, citing higher levels ofantibodies and inflammatory molecules associated with periodontaldisease in Alzheimer's patients over healthy people. The British MedicalJournal posted a study conducted by researchers at Brown Universitystating that individuals with high levels of Porphyromonas gingivalisbacterium had twice as great a risk of developing pancreatic cancer overindividuals with lower levels of these bacterium.

Oral care products traditionally have focused on taking either aspecific kill of a bacterium or to indiscriminately kill all bacteria.This thinking needs to be replaced with an approach that improves theenvironment to change the bacterial balance in the mouth in a safe waythat will have a healthier and more balanced affect long term.

The use of light and heat in oral care is known to kill bacteria in the470-490 nm wavelength range. The use of light alone will have an impactspecifically on p. gingivalis and to eliminate this bacteria.

We also know that the light and antibacterial approaches attacking theorganisms will only have a short term effect.

What has not been used in the past is a mouthpiece with light and heatbuilt inside, that creates a sealed gasket effect for any formulationthat will be placed inside of it. It would be advantageous to couple amouthpiece with a formulation that changes a gel to foam when warmedalong with the mouthpiece that has light and heat installed therein. Auniversally shaped mouthpiece allows for a custom fit as its internalflex circuit shapes to the user's mouth when they bite down on itsplatform area.

It would be advantageous for the light and heat of a mouthpiece toactivate a formulation to transform it from a gel to foam. Such a foamincreases in volume and as contained in the closed system mouthpiecedrives its active ingredients to the very difficult areas that requiremeticulous plaque control. These areas between the teeth, furthest areasback in the mouth and on the tongue, need this level of diligence.

People have always had trouble routinely brushing and flossing whichkeeps the bacteria in a healthy balance of good vs. bad bacteria. Oncethe plaque is allowed to form on the teeth close to the gums, over thecourse of just a few days, the bacterial microflora change to the morepathogenic anaerobes that cause disease. The oral care regimen needs tobe easy to use, short in duration, healthy and safe long term, and mustfit into people's lifestyles. In the past, minutes of brushing and 2minutes to floss has not seen great success because of the techniquesensitivity (user's ability) and the amount of time required to fit intopeople's busy lifestyles.

Applicant's original invention involves incorporation of light and heatto optimize the effectiveness of a whitening formulation by keeping theactives around longer and pushing them into the hard to reach areas towhiten. This mouthpiece has a warming element with a TPR or otherthermoplastic material that warms, softens, and conforms to the mouthupon use to create a peripheral seal around the outside of themouthpiece to seal actives inside. The universal mouthpiece, because ofthe flexible circuits, fits to any mouth, any arch form and thethermoplastic material forms the peripheral seal closed system.

The mouth is a dark, moist environment, where the hard to reach areasare void of oxygen, creating the perfect living headquarters for theanaerobic bacteria that thrive and cause the most damage.

It is known in the prior art to measure the level of acidity or basiccharacteristic within a person's mouth. However, Applicant is unaware ofany prior art teaching measuring of the pH in the mouth of a user in themanner contemplated in the present invention. Applicant is aware of thefollowing prior art:

U.S. Published Patent Applications 2005/0113654 to Weber et al.2011/0053173 to Hood et al. 2008/0233541 to De Vreese et al.2012/0123225 to Al-Tawil 2009/0017422 to Creamer 2012/0165694 to Meka etal. 2009/0132011 to Altshuler et al. 2012/0172677 to Logan et al.2009/0281433 to Saadat et al. 2012/0172678 to Logan et al. 2010/0081957to Hyde et al. 2012/0172679 to Logan et al.

U.S. Patents 5,674,182 to Suzuki et al. 6,607,387 to Mault.

While each of these references teaches some aspect of sensing pH, noneof them teaches the manner of doing so contemplated in the presentinvention.

Generally speaking, it is known in the prior art to utilize light atdesired wavelengths to kill orally located germs. Applicant is aware ofthe following prior art references:

U.S. Published Patent Applications 2004/0010299 to Tolkoff et al.2012/0021375 to Binner et al. 2008/0032252 to Hayman et al. 2012/0207806to LoPesio. 2012/0009539 to Goodson et al.

U.S. Patents 7,223,270 to Altshuler et al. 7,329,274 to Altshuler et al.7,223,281 to Altshuler et al. 7,354,448 to Altshuler et al. 7,329,273 toAltshuler et al. 7,422,598 to Altshuler et al.

The prior art references listed above generally disclose the use oflight to kill bacteria, the use of light intra-orally, the use of thecombination of mouthpieces and solutions to kill mouth bacteria, and theuse of light in a toothbrush for oral phototherapy. Hayman et al.disclose use of a mouthpiece and use of light to kill bacteria.

While these references teach the concept of using light to kill bacteriain the mouth, in a general sense, none of these references taken aloneor in combination with other references teaches or suggests the specificmanner by which the present invention employs a mouthpiece, heat andlight, and a foaming substance within a hermetically sealed environmentto retain or restore an advantageous pH level within the mouth of a userto maintain oral health and general health.

SUMMARY OF THE INVENTION

The present invention relates to a closed system mouthpiece with lightand heat generation to activate a formulation to increase its volume.The present invention includes the following interrelated objects,aspects and features:

(1) The present invention employs a gel formulation that may be coatedinto a mouthpiece, the mouthpiece subsequently being inserted into themouth of the user.

(2) Application of heat above a threshold temperature causes the gel totransform into foam and expand out of the mouthpiece and into the oralcavity.

(3) The mouthpiece is specifically designed to create a hermetic sealsuch that the mouth behind the teeth is transformed into a sealedchamber. Thus, when the application of heat causes the gel to expandinto foam, the foam expands out throughout the oral cavity into nooksand crannies that are normally difficult to access.

(4) With the foam so dispersed within the oral cavity, activation of alight source embedded within the mouthpiece enhances the bacteriakilling properties of the now foam material. This sealing property ofthe mouthpiece is described by Applicant as a “gasket effect.”

(5) The foam spreads onto the tongue of the user as well and acts tokill any damaging bacteria found there. As a result of operation of thepresent invention, the pH balance of the mouth is restored to a neutrallevel in the range of 6.75 to 7.25 or maintained at that pH level inwhich a healthy balance is maintained between various species ofbacteria. With damaging bacteria killed through use of the mouthpieceand the gel transforming into foam, the pipeline feeding damagingbacteria throughout the body is cut off, thereby enhancing overallhealth of the user.

As such, it is a first object of the present invention to provide amouthpiece with integral light and heat sources to facilitateilluminating and heating the inside of the mouth of a user.

It is a still further object of the present invention to provide such adevice in which a gel may be coated, which gel expands into foam whenexposed to heat above a threshold temperature.

It is a still further object of the present invention to provide such amouthpiece including structure to create a hermetic seal about the teethand gums of the user to seal the oral cavity from outside the mouth tofulfill the purposes of the present invention. The structure of thegasket effect of the mouthpiece includes a peripheral flange thatcreates a “gasket flange” that has a wiper blade and a rolled peripheralseal to ensure a tight seal to create a sealed environment.

It is a yet further object of the present invention to provide such asystem in which the foam expands throughout the oral cavity to killanaerobic bacteria (bacteria that live without oxygen) in the hard toreach places and restore the pH of the mouth to within a healthy range.

It is a yet further object of the present invention to activate a sourceof light within the mouthpiece to perform additional therapeuticfunctions.

It is a yet further object of the present invention to provide such amouthpiece in which a pH sensor is integrally mounted to facilitateclose monitoring of the pH of the mouth to fulfill the therapeuticpurposes of the present invention. The pH sensor will tell the wearerwhen their mouth is healthy, and using specific formulations willimprove the overall health through pH detection.

These and other objects, aspects and features of the present inventionwill be better understood from the following detailed description of thepreferred embodiments when read in conjunction with the appended drawingfigures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of the inventive mouthpiece withportions broken away to show details of the embedded flexible circuit.

FIG. 2 shows a cross-sectional view which depicts how the flexiblecircuit is located embedded within the mouthpiece and the mouthpieceeffects a hermetic seal of the oral cavity.

FIG. 3 shows a further perspective view of the inventive mouthpieceshowing further details including those of aspects of its pH sensor.

FIG. 4 shows a side view of the inventive mouthpiece showing theelectrodes of the pH sensor.

FIG. 5a shows a schematic representation of some of the circuitry of theinventive mouthpiece.

FIG. 5b shows a circuit diagram of one embodiment of circuitry.

FIG. 5c shows a circuit diagram of a second embodiment of circuitry.

FIGS. 6-17 show the sequence of intended operation of the inventivemouthpiece.

SPECIFIC DESCRIPTION OF THE PREFERRED EMBODIMENT

With reference first to FIGS. 1 and 2, the inventive mouthpiece isgenerally designated by the reference numeral 10 and includes a bitesurface 12, central and perpendicular to the main body 14, and whichextends outwardly from a central portion of the inner surface of themain body on one side thereof as best seen in FIG. 2. The bite surface12 is configured to ensure stability of the mouthpiece 10 when it ispositioned in the user's mouth between the upper and lower arches. Thebite surface 12 may be formed from two or more segmented or separatedportions, or, alternatively can be made of a single continuous bitesurface 13. The segmented bite surface is preferred because it betterallows for adjustments in the curvature of the mouthpiece 10 to moreeasily adapt to mouths of differing shapes and configurations. Themouthpiece includes a double seal bead 18 (FIGS. 1 and 2) extendingabout its periphery that is designed to seal at just above the gummargins to provide a hermetic sealed environment within the oral cavitywhen the mouthpiece is in place. The double seal bead includes a sealbead 3 and a wiper blade 5. These seals extend about the periphery ofthe mouthpiece 10 and seal at the margin of the gums 2, thereby creatinga closed chamber in the oral cavity, isolating the teeth 4 from theatmosphere. The lips 6 of the user lie over the body of the mouthpieceas seen in FIG. 2 to further enhance sealing effect. A plurality oftextured bands 16 (FIG. 1) are also provided, specifically designed tochannel LED light more diversely over the entirety of the teeth and oralcavity. The bite surface 12 is specifically designed to be transparentso that light from the LEDs embedded within the mouthpiece (as will bedescribed in greater detail hereinafter) and co-planar with the bitesurface 12 can find its way behind the teeth and into the oral cavityfor purposes to be described in greater detail hereinafter. As explainedabove, reflective surfaces within the mouthpiece enhance lighttransmission and its spread within the oral cavity. Reflective surfacesare also provided in the mouthpiece to guide light from the LEDs 24 intothe oral cavity.

Embedded within the mouthpiece 10 is a flexible circuit board 22 thathas integrally mounted therein two rows of heat generating resistors 26between which is a single row of illuminating LEDs 24. The flexibilityof the circuit board 22 permits the mouthpiece 10 to be bent to adapt todiffering curvatures and configurations of differing user mouths. In thepreferred embodiment of the present invention, the inner surface 30 ofthe mouthpiece above and below the bite surface 12 is tilted inward atan angle in the range of 5 to about 15 degrees to enhance the seal ofthe peripheral bead 18. This is seen with particular reference to FIG. 2which shows, schematically, a tooth 34 as well as the gum 35 with theseal bead 18 sealing at the margin between the tooth 34 and the gum 35so that beams of light 32 impinge upon all of the tooth surfaces, inuse. Reference numeral 20 depicts an electrical conductor which suppliespower to the flexible circuit board 22 from a source of power not shownin FIGS. 1 and 2. Many of the details described above are also found inApplicant's prior U.S. Pat. No. 8,371,853, the details of which areincorporated by reference herein.

The inventive mouthpiece disclosed in U.S. Pat. No. 8,371,853 wasdisclosed as principally usable for teeth whitening. It was alsodisclosed as usable in methods of desensitizing teeth, acceleratinghealing of mouth sores or ulcerations, for treating gum disease orfreshening a patient's breath. The present invention expands upon theuses contemplated in Applicant's prior mouthpiece invention by operatingin conjunction with a formulation usable for other purposes.

In particular, the present invention is intended to be used inconnection with a gel formulation which when heated above a thresholdtemperature transforms into foam dramatically expanding its volume andspreading throughout the oral cavity for the purposes disclosed herein.Such a gel may include as constituent ingredients including PEG-8,propylene glycol, canola oil, hydrogen peroxide, glycerin,dimethylisosorbide, a formulation of poloxamer ascorbic acid, xylitol,and other substances including flavoring and coloration. In essence, thesubstance employed may be spread over the surfaces of the mouthpiece andmaintains its gel consistency at room temperature. However, when placedin the mouth, the mouth temperature begins to raise the temperature ofthe gel. When the heating resistors 26 are activated, they elevate thetemperature of the mouth over 100° F. At the designed temperaturethreshold, the gel begins to expand, transforming into foam that beginsto spread throughout the oral cavity coating all of the tooth surfacesas well as the surfaces of the oral cavity including the tongue, theroof of the mouth, interstices between teeth and gums, and other hard toreach areas. In the preferred embodiment, the gel begins to slowlytransform into foam at the normal temperature of the oral cavity, 37° C.With the heating resistors 26 activated, at 40° C., the transformationspeeds up. The heating resistors 26 can heat the oral cavity to up toabout 50° C., a high enough temperature to quickly transform the gelinto foam without making the user uncomfortable from the heat.

With reference to FIGS. 3, 4 and 5 a, the mouthpiece 10 has a grippingtab 15 that may be gripped by the user in placing the mouthpiece 10within the oral cavity. The gripping tab 15 also includes a display 27that includes a series of lights 29, 31, 33 and 35. Those lightscomprise a display used in conjunction with a pH sensor incorporatedinto the inventive device. With reference to FIG. 4, the electrodes 37and 39 are located on the mouthpiece 10 in a location in which they areconsistently immersed in saliva. The saliva between the electrodes 37and 39 closes an electrical circuit that may be measured as a voltagethat corresponds to the pH of the oral cavity. FIG. 5a shows theelectrode 37 embedded within the mouthpiece 10 and including a conductor41 preferably made of a material such as copper.

In more detail, the pH sensor electrodes 37 and 39 are made of a pHsensitive material and are electrically connected to the flexiblecircuit board 22. The preferred location for the electrodes is at eitherend of the arch of the mouthpiece 10. The electrodes may be made of anysolid material that develops hydrogen ion dependent electricalpotentials. Such materials include Iridium Oxide, Silver Chloride,Graphene, Carbon Nanotubes, and other Nano materials.

As the electrodes are exposed to saliva, they develop a measurableelectrical potential. The electrical potential on the electrodes ismeasured as a voltage and correspondingly increases or decreasesresponsive to the pH value of the saliva. The voltage measured at thesensor is computed by a microprocessor in the mouthpiece and convertedinto an indication of the pH. The measured pH is displayed by the colorcoded lights 29, 31, 33 and 35 of the display 27, in one embodimentthereof. In one embodiment of color-coded indicator lights, a greenindicator light can be used to signify a pH of saliva within a healthyrange, for example, 6.75 to 7.25. A red indicator light can be used tosignify a pH of saliva in an unhealthy range, for example, below 6.75.In another variation, the red and green lights can be programmed toilluminate responsive to other pH ranges. Thus, the green light can beilluminated to signify a healthy pH for saliva where the pH is 7.0 orhigher, and the red light can be illuminated to signify a saliva pH ofbelow 7.0. In another embodiment, the display can be separate from themouthpiece and the microprocessor can be connected to the display via aremote wired or wireless link. In either embodiment, a preferred mannerof practicing the present invention is to measure the pH of saliva inthe user's oral cavity before the mouthpiece is coated with gel andbefore the LEDs and heating resistors are activated. In this way, thebaseline measurement of pH before treatment can be established so thatrestoration of the pH to a healthy range can be demonstrated. As is wellknown by those of ordinary skill in the art, pH below 7.0 signifiesacidic saliva which demonstrates the existence of active disease.Through practice of the present invention, the pH of saliva in the oralcavity is elevated to a neutral pH signifying a healthy oral cavity.

In more detail, it is well known by those of ordinary skill in the artthat the pH of a liquid can be measured by employing two spacedelectrodes. As explained in WHAT IS pH, AND HOW IS IT MEASURED? ATechnical Handbook for Industry, by Frederick J. Kohlmann, © 2003 HachCompany (which is incorporated by reference herein), in the 19^(th)century, Hermann Walther Nernst introduced the Nernst equation whichresulted in definition of the Nernst factor which provides the amount ofchange in total potential for every ten-fold change in ionconcentration. In essence, Nernst determined that for every pH unitchange, the total electrical potential will change by 59.16 mV.

With this information in mind, Kohlmann describes the use of a pair ofelectrodes, one of which is a reference electrode, and the other ofwhich is a measuring electrode. When the measured potential betweenthese two electrodes is zero, this equates to a pH measurement of 7.0,neutral pH. As the solution becomes more acidic (a pH below 7), the mVpotential becomes more negative at a rate of 59.16 mVs for every unitreduction in the pH value. Thus, a voltage reading of −59.16 mVs equatesto a pH of 6.0. Conversely, as the solution becomes more basic (a pHabove 7), the mV potential becomes more positive at a rate of 59.16 mVsfor every unit increase in the pH value. Thus, a voltage reading of+59.16 mVs equates to a pH of 8.0. With this information in hand, it iseasy to see how one of ordinary skill in the art can devise a display,whether analog, digital, or employing indicator lights, to indicate tothe user the pH of saliva within the oral cavity of the user, whichsaliva immerses the spaced electrodes.

With reference to FIGS. 5b and 5c , two examples of electrical circuitryusable in connection with the present invention are schematically shown.With reference to FIG. 5b , a source of power is schematically shownreferred to by reference numeral 45. This may comprise a batterycontained within the mouthpiece 10 or, alternatively, the source ofpower remotely located and connected via the conductor 20 (FIGS. 1 and2). In either event, an on-off switch 47 controls activation anddeactivation of the system. In FIGS. 5b and 5c , the heating resistors26 and LED 24 are schematically shown. Reference numeral 36 refers to acombination sensor microprocessor while the associated display isreferred to with reference numeral 49. In the circuit of FIG. 5b , themicroprocessor is connected to the display via a hard wired electricalconductor 51. In the embodiment of FIG. 5c , the microprocessor isconnected to a transmitter 53 which has an antenna 55 that transmitssignals corresponding to the pH via the antenna 55 to a receiver 57antenna 59 which then provides the information via a conductor 61 to thedisplay 49.

With reference to FIGS. 6-17, the manner of operation of the presentinvention in its preferred mode of operation will now be described.

With reference to FIG. 6, gel from a canister thereof is applied to theupper and lower areas of the mouthpiece 10 above and below the bitesurface 12. With reference to FIG. 7, the mouthpiece is inserted intothe mouth and the LEDs 24 and heat resistors 26 are activated.

With reference to FIGS. 8 and 9, the peripheral bead 18 of themouthpiece 10 creates a seal at the margin between the teeth and gums sothat the oral cavity of the user is completely sealed off from theoutside environment.

With reference to FIGS. 10-11, when the temperature of the oral cavityrises above a threshold temperature, typically over 100 degrees F., thegel transforms into foam and expands over the teeth, gums, roof of themouth, tongue, and other areas and interstices of the oral cavity.

With reference to FIGS. 12-15, the foam kills off undesirable bacteriafrom the tooth enamel, tongue, and other oral cavity surfaces. As aresult, the tongue, teeth, and oral cavity are cleansed of harmfulbacteria and the pH of the oral cavity rises to the healthy range of6.75 to 7.25. The pH of the oral cavity is continually monitored duringthe process via the display 27 (FIG. 3) or 49 (FIGS. 5b and 5c ). In thedisplay 27, each light corresponds to a unique pH or pH range. Once thepH of the oral cavity has been restored to within the healthy range, themouthpiece 10 may be deactivated and removed from the mouth and the oralcavity may be rinsed to remove the foam therefrom.

Treatments such as that which is described above may be repeated on adaily basis or multiple times during a day to maintain the pH of theoral cavity within a healthy range to not only enhance the health of theuser's oral cavity, but to enhance health generally.

The present invention takes a unique formulation that works inconjunction with the closed system mouthpiece that has heat and lightactivating the gel to increase volume and change into a foam. This foamcan expand against the walls of the oral cavity and push its contentsinto these dark, oxygen poor areas where the “bad” bacteria thrive. Theobjective is to change the environment from oxygen poor-low pH lovingsites where the pathogenic bacteria thrive to a safer, more effectiveway to rebalance homeostasis in the mouth towards health.

Applicant has devised four separate formulations of gels thateffectively fulfill the objects and purposes of the present invention. Afirst formulation includes a mixture of PEG-8, Propylene Glycol, CanolaOil, PVP-Hydrogen Peroxide K-90 (1.7% peroxide), Glycerin, DimethylIsosorbide, Poloxamer 407, Ascorbic Acid, Green Tea Extract, VitisVinifera (Grape Seed) Extract, Sodium Bicarbonate, Flavor, Xylitol, andAqua. A second formulation includes a mixture of PEG-8, PropyleneGlycol, Canola Oil, PVP-Hydrogen Peroxide K-30 (1.7% peroxide),Glycerin, Dimethyl Isosorbide, Poloxamer 188, Xylitol, Ascorbic Acid,Green Tea Extract, Vitis Vinifera (Grape Seed) Extract, Flavor, andAqua. A third formulation includes a mixture of PEG-8, Propylene Glycol,Canola Oil, Glycerin, PVP-Hydrogen Peroxide K-90, Dimethyl Isosorbide,PVP-Hydrogen Peroxide K-30, Xylitol, Poloxamer 188, Flavor, PotassiumOlivoyl Hydrolyzed Oat Protein, Sorbitol, Tocopheryl Acetate,Tetrahexyldecyl Ascorbate, Green Tea Extract, Vitis Vinifera (GrapeSeed) Extract, Aqua, Mica, Titanium Dioxide, Sodium Bicarbonate,Hydrogenated Cotton Seed Oil, and Potassium Chloride. A fourthformulation includes a mixture of PEG-8, Propylene Glycol, Canola Oil,Glycerin, PVP-Hydrogen Peroxide K-90, PVP-Hydrogen Peroxide K-30, FumedSilica (Vendor #2), Dimethyl Isosorbide, Potassium Olivoyl HydrolyzedOat Protein, Stevia Glucosides, Tocopheryl Acetate, Hydrogenated CottonSeed Oil, Tetrahexyldecyl Ascorbate, Xylitol, Flavor (Flavorchem),Sorbitol, Aqua, Sodium Bicarbonate, Potassium Chloride, Mica, andTitanium Dioxide.

The invention defines a mouthpiece that uses light and heat in a closedsystem and a peripheral seal that works in conjunction with aformulation that transforms from a gel to a foam upon application ofheat. Once the foam expands into a closed system, the gasket effect ofthe closed container seals all contents and optimizes the formulation'seffect. The gasket seal 3, 5 gives an additional layer of protection toprevent oxygen escape at the periphery of the mouthpiece where it meetsthe soft tissue of the gums and the lips.

There is a desire to change the pH of the mouth with a formulation thatdeodorizes the mouth and oxygenates the teeth and gums therebydecreasing the population of the anaerobic gram negative bacteria thatcauses gum disease, bad breath and tooth sensitivity. By raising the pH,the acid producing bacteria of decay will also be arrested in this morefavorable environment.

As such, an invention has been disclosed in terms of a preferredembodiment thereof as well as a preferred manner of use, that fulfilleach and every one of the objects of the invention as set forthhereinabove, and provide a new, useful and unobvious closed systemmouthpiece with light and heat generation to activate a formulation toincrease its volume, of great novelty and utility.

Of course, various changes, modifications and alterations in theteachings of the present invention may be contemplated by those skilledin the art without departing from the intended spirit and scope thereof.

As such, it is intended that the present invention only be limited bythe terms of the appended claims.

The invention claimed is:
 1. A method of treating an oral cavity of auser, including the steps of: a) providing a mouthpiece in which atleast one heat source is embedded and connectable to a source of power;b) said mouthpiece including a peripheral sealing member comprising twoconcentric sealing members; c) coating rearward facing surfaces of saidmouthpiece with a gel; d) inserting said mouthpiece into said oralcavity with said sealing member sealing said oral cavity; e) activatingsaid at least one heat source and raising temperature of said gel untilsaid temperature reaches a threshold temperature at which said geltransforms into a foam and spreads within said oral cavity; f)maintaining said mouthpiece sealing said oral cavity for a desired timeperiod; g) after said desired time period has expired, removing saidmouthpiece and rinsing said oral cavity.
 2. The method of claim 1,further including the step of providing said mouthpiece with a bite tabextending rearwardly central of a main body of said mouthpiece, saidbite tab having upper and lower surfaces engageable by a user's teeth.3. The method of claim 1, wherein said concentric sealing memberscomprise a first peripheral seal comprising a seal bead and a secondperipheral seal comprising a wiper blade.
 4. The method of claim 3,wherein said wiper blade is concentrically outside said seal bead. 5.The method of claim 2, wherein said main body also contains at least onelight source embedded therein.
 6. The method of claim 5, furtherincluding the step of providing a flexible circuit board embedded withinsaid main body and carrying said at least one heat source and at leastone light source.
 7. The method of claim 6, wherein said at least oneheat source comprises an array of heat sources.
 8. The method of claim7, wherein said at least one light source comprises an array of lightsources.
 9. The method of claim 1, further including the step ofproviding said mouthpiece with a pH sensor immersible in saliva withinsaid oral cavity.
 10. The method of claim 9, further including the stepof providing said pH sensor with an indicator indicating pH value withinsaid oral cavity.
 11. The method of claim 10, further including the stepof monitoring pH in said oral cavity and removing said mouthpiece fromsaid oral cavity when said pH value is within a desired range.
 12. Themethod of claim 11, wherein said desired range is 6.75 to 7.25.
 13. Themethod of claim 11, wherein after said removing step, said methodincludes the step of rinsing said oral cavity.
 14. The method of claim10, wherein said indicator is carried by said mouthpiece.
 15. A methodof treating an oral cavity of a user, including the steps of: a)providing a mouthpiece in which at least one heat source and at leastone light source are embedded and connected to a source of power; b)said mouthpiece including a peripheral sealing member and a central bitetab extending rearwardly; c) coating rearward facing surfaces of saidbite tab with a gel; d) inserting said mouthpiece into said oral cavity,with said sealing member sealing said oral cavity; e) activating said atleast one heat source and raising temperature of said gel until saidtemperature reaches a threshold temperature at which said gel transformsinto a foam and spreads within said oral cavity; f) maintaining saidmouthpiece sealing said oral cavity; g) measuring pH of said oralcavity, and when pH of said oral cavity is within a desired range,removing said mouthpiece and rinsing said oral cavity.
 16. The method ofclaim 15, wherein said peripheral sealing member comprises twoconcentric sealing members, a first peripheral seal comprising a sealbead and a second peripheral seal comprising a wiper blade.
 17. Themethod of claim 15, further including the step of providing a flexiblecircuit board embedded within said main body and carrying said at leastone heat source and said at least one light source.
 18. The method ofclaim 17, wherein said at least one heat source comprises an array ofheat sources and said at least one light source comprises an array oflight sources.
 19. The method of claim 15, further including the step ofproviding said mouthpiece with a pH sensor immersible in saliva withinsaid oral cavity, said pH sensor being provided with an indicatorindicating pH value within said oral cavity.
 20. A method of treating anoral cavity of a user, including the steps of: a) providing a mouthpiecein which at least one heat source is embedded and connectable to asource of power; b) said mouthpiece including a peripheral sealingmember; c) coating rearward facing surfaces of said mouthpiece with agel; d) inserting said mouthpiece into said oral cavity with saidsealing member sealing said oral cavity; e) activating said at least oneheat source and raising temperature of said gel until said temperaturereaches a threshold temperature at which said gel transforms into a foamand spreads within said oral cavity; f) maintaining said mouthpiecesealing said oral cavity for a desired time period; g) after saiddesired time period has expired, removing said mouthpiece and rinsingsaid oral cavity; and h) further including the step of providing saidmouthpiece with a pH sensor immersible in saliva within said oralcavity.
 21. The method of claim 20, further including the step ofproviding said pH sensor with an indicator indicating pH value withinsaid oral cavity.
 22. The method of claim 21, further including the stepof monitoring pH in said oral cavity and removing said mouthpiece fromsaid oral cavity when said pH value is within a desired range.
 23. Themethod of claim 22, wherein said desired range is 6.75 to 7.25.
 24. Themethod of claim 22, wherein after said removing step, said methodincludes the step of rinsing said oral cavity.
 25. The method of claim21, wherein said indicator is carried by said mouthpiece.